(30 days)
The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.
The LifeBed Network Patient Vigilance System ("LifeBed Network") is composed of a bedside unit (either a LifeBed Display or Vigilance Display, generically referred to as a Display), a sensor array packaged in the form of a mattress coverlet, and the LifeBed Controller. The LifeBed Displays are optionally equipped with a wireless adapter. The LifeBed Network Patient Vigilance System collects, stores, and reports patient medical and status information. Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiratory rate, whether the patient is in bed, and any alerts. The configuration of a Display may be changed on the Display or remotely from the LifeBed Network. The Displays are connected to the LifeBed Controller via a TCP/IP network which is provided by the customer. This network may be wired (using Ethernet), or wireless (using WiFi) as required by the facility. The hub of the LifeBed Network is the LifeBed Controller'), which serves one unit (e.g., a hospital ward). From the Controller a user has access to the collected information and the ability to view and modify the configuration of connected Displays. The LifeBed Network provides an interface which may be used to integrate with a Clinical Information System (CIS). When used in this way an auxiliary adapter isolates and translates the protocols between the LifeBed Network and the CIS. This interface allows the collected data and stored configuration for the Displays. The LifeBed Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are communicated by the Display to the Nurse Call system of the hospital. All user access to the LifeBed Network is constrained by a security system. Each user is authenticated by a user name and password and their ability to access data is controlled by their assigned role.
This document is a 510(k) premarket notification for an update to the LifeBed Network Patient Vigilance System. The 510(k) summary explicitly states that no clinical trials were performed in support of this submission. Therefore, it does not contain information about acceptance criteria, device performance from clinical studies, sample sizes, ground truth establishment, or expert involvement as requested.
The submission focuses on software changes to the LifeBed Controller; it relies on previous testing for substantial equivalence. The document clearly states:
- "No changes were made to the LifeBed Patient Vigilance System (KO82366) which contains the algorithm and control of the patient interface. The LifeBed Network only adds the networking and data collection capabilities. No clinical trials were performed in support of this submission." (Section labeled "Clinical Testing")
- "All verification and validation testing conducted demonstrate that this release of the LifeBed Network Patient Vigilance System is substantially equivalent to the prior release (K092037)." (Conclusion)
Therefore, I cannot provide the requested information from the provided text.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).